Status:
COMPLETED
A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering
Lead Sponsor:
Endo Pharmaceuticals
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Stuttering
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering.
Detailed Description
A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension ph...
Eligibility Criteria
Inclusion
- Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old.
- Stuttering severity must be notable for \> 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually from conversational and reading tasks.
Exclusion
- Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00830154
Start Date
February 1 2009
End Date
January 1 2011
Last Update
August 28 2012
Active Locations (1)
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1
Indianapolis, Indiana, United States